Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients

Inclusion Criteria:

- The subject has severe or moderately severe hemophilia A as defined by a baseline
factor VIII level <= 2% of normal, as documented at screening

- The subject is < 6 years of age

- The subject's legally authorized representative has provided written informed consent

Exclusion Criteria:

- The subject has a history of exposure to factor VIII other than rAHF PFM or more than
3 infusions of commercially available rAHF PFM (i.e., ADVATE) within 28 days prior to
screening, as determined by the subject's medical history. Any infusion of factor VIII
replacement products prior to the 28-day period excludes the subject from
participation

- The subject has received more than 3 infusions of rAHF PFM (commercially available
and/or study product) between screening and prior to the initial recovery infusion

- The subject has a detectable inhibitor to factor VIII, as measured in the screening
sample by the Nijmegen assay in the central laboratory

- The subject has a history of inhibitor to factor VIII at any time prior to screening

- The subject has a known hypersensitivity to rAHF PFM

- The subject has any 1 of the following laboratory abnormalities at the time of
screening:

1. Platelet count < 100,000/mm^3

2. Hemoglobin concentration < 10 g/dL (100 g/L)

3. Serum creatinine > 1.5 times the upper limit of normal (ULN) for age

4. Total bilirubin > 2 times the ULN for age

- The subject has an inherited or acquired hemostatic defect other than hemophilia A
(e.g., qualitative platelet defect or von Willebrand's disease)

- The subject is known to be seropositive for human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV), as determined by the subject's
medical history

- At the time of enrollment, the subject has a clinically significant chronic disease
other than hemophilia A

- The subject is currently participating in another investigational drug study, or has
participated in any clinical study involving an investigational drug within 120 days
of the screening visit

- The subject (or the subject's legally authorized representative) is identified by the
investigator as being unable or unwilling to cooperate with study procedures

- The subject has received any blood product, including packed red blood cells (RBC),
platelets, plasma, or cryoprecipitate